Over-the-counter (OTC) bruxism splints available on the Internet.

BACKGROUND: Some individuals may now be bypassing their dentists for treatment of bruxism. Self-diagnosed, self-adjusted and self-monitored consumers can access over-the-counter (OTC) bruxism splints via the Internet. While some may regard this market as benefiting consumers there are potential pitfalls that need to be highlighted. These include unevidenced claims of efficacy. OBJECTIVE: To survey OTC bruxism splints available to individuals in the UK via the Internet, categorise their characteristics, and determine any web-based claims or safety warnings. MATERIALS AND METHODS: An Internet search was made of OTC bruxism splints available in the UK. The following information was recorded for each OTC splint: the name of the manufacturer, name of the device, its UK price and any claims and safety warnings made either on a major UK retail website or via other UK web retail outlets. In addition, a note was made of any web-based mention of 'CE marking', indicating compliance with the EC Medical Devices Directive's requirements for safety, quality and performance. RESULTS: Safety information is notable for its paucity and is totally lacking on many Internet sites. However, manufacturers are not obliged to display safety information on the Internet, but it must be provided with the product. A search of the MAUDE database showed a number of potentially serious adverse events associated with these splints including choking hazards, tissue damage and occlusal changes. None of the splint designs assure full occlusal coverage. CONCLUSIONS: As with any partial coverage appliance, if worn for protracted periods there may be a risk of unwanted tooth movement. Dentists should report or assist patients with reporting suspected adverse events with OTC splints to the relevant competent authority. In the UK this is the Medicines and Healthcare Products Regulatory Agency (MHRA).

Cardiovascular autonomic function testing under non-standardised and standardised conditions in cardiovascular patients with type-2 diabetes mellitus.

Autonomic function tests require standardised test conditions. We compared testing under non-standardised and standardised conditions and investigated the agreement between heart and pulse rate variability in 30 subjects with diabetes mellitus. Deep breathing, Valsalva manoeuvre and quick standing tests showed non-standardised reproducibility intraclass correlations (95% CI) of 0.96 (0.82-0.99), 0.96 (0.81-0.99) and 0.75 (-0.98 to 0.94), respectively. Intraclass correlations for sustained handgrip and quick standing were poor. Heart and pulse rate variability showed high-frequency band intraclass correlations (95% CI) of 0.65 (-0.07 to 0.89) and 0.47 (-0.88 to 0.85) for the very low-frequency band, respectively, 0.68 (0.00-0.90) and 0.70 (-0.09 to 0.91) for the low-frequency band, and 0.86 (0.57-0.95) and 0.82 (0.39-0.95) for the high-frequency band. Reproducibility under standardised conditions was comparable. The mean difference (95% limits of agreement) between heart and pulse rate variability was 0.99 (0.80-1.22) for very low frequency, 1.03 (0.88-1.21) for low frequency and 1.35 (0.84-2.16) for high frequency, with a Spearman's correlation coefficient of 1.00, 0.99 and 0.98, respectively. We demonstrated a high agreement between heart and pulse rate variability and acceptable reproducibility with most autonomic function tests, heart and pulse rate variability.

A multicentre European registry of intraluminal coronary beta brachytherapy.

AIMS: To assess the feasibility, safety and effectiveness of intravascular brachytherapy (VBT) in routine clinical practice. METHODS AND RESULTS: Between April 1999 and September 2000, 1098 consecutive patients treated in 46 European centres by intraluminal irradiation using a Sr/Y(90)source train (BetaCath, Novoste, GA) were included in a registry, and follow-up data were obtained for 98.8% of them after 6.3+/-2.4 months. Eight hundred and forty (76.5%) patients were males, and mean age was 62.0+/-10.2 years. Two hundred and seventy-one (26.9%) had unstable angina, and 256 (23.5%) were diabetics. Nine hundred and thirteen lesions (77.7%) were the result of in-stent restenosis, 208 (17.7%) were de novo lesions and 48 (4.1%) non-stented restenotic lesions. Mean estimated reference diameter was 3.2+/-0.5mm and mean estimated lesion length was 19.0+/-11.8mm. The prescribed radiation dose was 18.8+/-3.2Gy. Multivessel irradiation was done in 6.2% of cases, and a new stent was implanted in 29.6% of cases. Most patients received 6 or 12 months of combined aspirin and thienopyridin treatment after the procedure. Technical success was obtained in 95.9% of treated lesions, and the in-hospital major adverse cardiac event (MACE) rate was 1.8%. At follow-up, the MACE rate was 18.7% (1.9% deaths from any cause, 2.6% AMI, 13.3% TVR by PCI and 3.3% TVR by CABG). CONCLUSION: The major current application of VBT is the treatment of in-stent restenosis. The good results of VBT observed in recent randomized controlled trials can be reproduced in clinical practice.